Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune
system in different ways and stop cancer cells from growing. Drugs used in chemotherapy,
such as melphalan, work in different ways to stop the growth of cancer cells, either by
killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make
cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with
melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together
with melphalan works in treating patients with relapsed multiple myeloma.
OBJECTIVES:
Primary
* To evaluate the hematological response rate of anti-thymocyte globulin given in
combination with melphalan in patients with relapsed multiple myeloma.
Secondary
- To assess the toxicity and tolerability of this combination in these patients.
- To assess time to disease progression in patients treated with these drugs.
- To assess survival of patients treated with these drugs. OUTLINE: Patients receive
anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats
every 28 days for 6 courses. Patients then receive melphalan alone as above for another
6 courses. Treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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